Comparing Extended and Standard Letrozole Therapy for Ovulation Induction in Women with Polycystic Ovary Syndrome

What this Trial Is About

Researchers are evaluating the efficacy and safety of extended letrozole therapy compared with standard letrozole therapy for ovulation induction in women with polycystic ovary syndrome PCOS. This randomized clinical trial involves 84 women aged 18 to 40 years diagnosed with PCOS. The study aims to determine if a longer duration of letrozole treatment improves ovulation and pregnancy outcomes, addressing ongoing questions about optimal therapy length for anovulatory infertility. Participants are assigned to one of two groups the standard therapy group receives 5 mg of letrozole daily for 5 days cycle days 2 to 6, while the extended therapy group takes 5 mg daily for 10 days cycle days 2 to 12. Ovulation will be monitored by transvaginal ultrasound and confirmed by urinary LH testing or corpus luteum visualization to compare the effects of both regimens. Throughout the study, participants undergo ovulation monitoring and assessments of mature follicle number and size, clinical pregnancy rates, miscarriage rates, multiple pregnancies, and ovarian hyperstimulation syndrome incidence. The primary outcome is the ovulation rate within one treatment cycle, and secondary outcomes include pregnancy-related measures tracked up to 12 weeks. The study starts in September 2025 and ends in July 2026, with all procedures conducted under medical supervision.

Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)